Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jiangsu Micsafe Medical Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
216 daysmedian FDA review time
301 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212019 | Blood Collection Needle for Single Use & Blood Collection Ne | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-11-04 | 129 | 0 |
| K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-07-02 | 301 | 0 |
| K202205 | Surgical Face Mask | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-03-09 | 216 | 0 |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety | Jiangsu Micsafe Medical Technology Co., Ltd. | 2019-09-06 | 253 | 0 |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/ | Jiangsu Micsafe Medical Technology Co., Ltd. | 2018-10-11 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda